Brexit: specific information for sponsors of clinical trials

date:

14/05/2019

The FAMHP is working closely with the affected parties to find a solution for clinical trials which may encounter problems after Brexit.

Without a withdrawal agreement after Brexit, the United Kingdom (UK) will be considered a third-party country. Thus an authorized representative in another European member state (EU 27) will be required for all clinical trials with a sponsor from the UK. Authorized representatives in the UK for non-EU sponsors will also no longer be valid.

More information about the change of authorized representative, the production of “Investigational Medicinal Products” (IMPs), batch release of IMPs and substantial amendments is found in a FAQ.